a study of cetuximab in patients who have stage iv colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this clinical research study is to learn about the safety of cetuximab in patients with stage iv colorectal cancer, and who may benefit from cetuximab.


Eligibility criteria:
inclusion criteria: * subjects must have signed an approved informed consent prior to any study procedures. * subjects with histologically or pathologically confirmed metastatic colorectal cancer, which is egfr-positive by ihc (may be based on archival samples) * subjects with ecog performance status 0, 1 or 2. * subjects who have failed, either due to lack of efficacy or due to intolerance, all available chemotherapy for the treatment of metastatic colorectal cancer. * subjects who have failed to meet eligibility criteria for any other existing cetuximab trial. * subjects must have received at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease, provided the subject progressed within 6 months of completing their adjuvant therapy. * prior chemotherapy must have included all of the follow drugs: irinotecan, oxaliplatin, and a fluoropyrimidine. * subjects adequately recovered from any recent surgery, radiation therapy or chemotherapy. * subjects accessible for treatment and follow-up. subjects enrolled in this trial must be treated at the participating center. * subjects greater or equal to 18 years of age. * women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks afterwards. exclusion criteria: * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. * women who are pregnant or breastfeeding. * women with a positive pregnancy test on enrollment or prior to study drug administration. * sexually active, fertile men not using adequate birth control. * subjects with dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * subjects with a serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy. * subjects with a history of uncontrolled angina, arrhythmias, congestive heart failure, or myocardial infarction within the previous 6 months. * subjects with any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. subjects with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial. * subjects with any history of severe hypersensitivity reactions and/or anaphylaxis resulting from the administration of protein based therapeutic agents. * subjects with inadequate hematologic function defined by an absolute neutrophil count (anc) \<1,250/mm3, a platelet count \<75,000/mm3, and a hemoglobin level \<8 g/dl. * subjects with inadequate hepatic function, defined by a total bilirubin level ³3 times the upper limit of normal (uln) and an aspartate transaminase (ast) and alanine transaminase (alt) levels \>5 x uln. * subjects with inadequate renal function defined by a serum creatinine level \>2.5 x uln. * prior cetuximab therapy, prior randomization on a study which includes cetuximab therapy in a treatment arm, or any other prior therapy that targets the egfr pathway. * a history of prior therapy with a chimerized or murine monoclonal antibody. * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. * a history of cetuximab or therapy that targeted the egfr receptor. * a history of prior anti-cancer murine monoclonal antibody therapy. * additional concurrent chemotherapy or other investigational anticancer agents may not be administered to subjects on this study.

Keywords: stage iv colorectal cancer